Kornimate/medical-research-clean huggingface dataset:
treatment of nasal airway obstruction using the aerin medical device

Conditions: Nasal Obstruction

Summary: evaluation of the aerin medical device used for the treatment of nasal obstruction.

this is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the aerin medical device (vivaer stylus) when used to deliver radiofrequency (rf) energy to the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Eligibility criteria:
inclusion criteria: * seeking treatment for nasal obstruction and willing to undergo an office-based procedure * nasal obstruction symptom evaluation (nose) score of ≥ 60 at baseline * nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam): * use of external nasal dilator strips (e.g., breathe right strips) * q-tip test (manual intranasal lateralization) * use of nasal stents * cottle maneuver (manual lateral retraction of the cheek) exclusion criteria: * prior surgical treatment of the nasal valve * rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past twelve (12) months * chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction * septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be a significant contributor to the subject's nasal obstruction symptoms * known or suspected allergies or contraindications for any general or local anesthetic agents and / or any antibiotic medications * known or suspected to be pregnant, or is lactating * other medical conditions which in the opinion of the investigator could predispose the subject to poor wound healing or increased surgical risk

Keywords: nasal valve nasal airway obstruction
cost of long term disability in patients with chronic non-specific low back pain

Conditions: Low Back Pain

Summary: the purpose of the study was to determine the cost-effectiveness of a function-centred treatment (fct) compared with a pain-centred treatment (pct) in patients with chronic low back pain (lbp) in an in-patient setting. follow-up lasted three years. direct and indirect costs were recorded by questionnaires sent to health insurances, employers and swiss disability insurance company.


Eligibility criteria:
inclusion criteria: * chronic low back pain, sick leave of 6 weeks during the last 6 months exclusion criteria: * not able to perform a training program

Keywords: low back pain economics cost-effectiveness
split-face prospective study comparing botox to xeomin for the treatment of facial wrinkles

Conditions: Facial Wrinkles

Summary: the aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxina to incobotulinumtoxina for the correction of facial wrinkles using a 1:1 dose ratio.

patients will be randomized to which side of the face will be injected with onabotulinumtoxina and incobotulinumtoxina. a total dose of 22.5 units of onabotulinumtoxina and 22.5 units of incobotulinumtoxina will be administered at baseline to the respected side of the face. one vial (100 mu) of bonta will be reconstituted with 2.0 ml of 0.9% sterile saline solution. similarly, one vial (100 mu) of btxco will be reconstituted with 2.0 ml of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). the duration of the study will be 4 months. the followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. at each of these visits, standardized digital photographs of the treated facial area will be taken. both static and dynamic photos will be taken of each region. at the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the validated assessment scaled for the upper face published by flynn et al 2012.

Eligibility criteria:
inclusion criteria: * males and females age 18 or older. exclusion criteria: * previous treatment with a neuromodulator in the last 6 months * previous brow lift * currently pregnant or breastfeeding * a history of neurological disease or deficit * an active facial skin infection * an allergy to neuromodulators
intubation during spinal immobilization

Conditions: Endotracheal Intubation

Summary: the aim was to evaluate the performance of the c-mac compared with macintosh when performed in patients with immobilized cervical spine by unexperienced physicians.


Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * limited experience (\<5 intubations) with "real-life" intubation using direct laryngoscopy * novice phhysicians exclusion criteria: * not meet the above criteria * practice with any videolaryngoscopy * wrist or low back diseases * pregnancy

Keywords: endotracheal intubation trauma paramedic
a sleep lab trial to investigate the efficacy and safety of transdermal rotigotine in subjects with idiopathic restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: the objective of this trial is to demonstrate that rotigotine (spm 936) is effective in subjects with idiopathic rls based on the plmi (periodic limb movements index)(plms/total time in bed) as measured by polysomnography (psg). the primary variable is the reduction of plmi at the end of the maintenance period compared to baseline. plmi data will be obtained from psgs.


Eligibility criteria:
inclusion criteria: * idiopathic rls exclusion criteria: * secondary rls * history of sleep disturbances * symptomatic orthostatic hypotension

Keywords: idiopthic restless legs syndrome
study comparing one versus two cortisone injections for trigger finger

Conditions: Stenosing Tenosynovitis; Trigger Finger

Summary: trigger finger, also known as stenosing tenosynovitis, is a painful condition that can cause discomfort and disability. many physicians choose to locally inject cortisone into the infected finger although there is no current consensus as to how many injections are needed to achieve maximum relief. this study will be a prospective, randomized study to compare one versus two injections for the treatment of trigger finger.


Eligibility criteria:
inclusion criteria: * subject is greater than 18 years of age, presenting with stenosing tenosynovitis. * subject is willing and able to provide informed consent. exclusion criteria: * patients who have previously undergone surgery for the treatment of trigger finger.

Keywords: trigger finger trigger thumb
efficacy and safety of three doses of vildagliptin in drug naive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility criteria:
inclusion criteria: * not currently on drug therapy for type 2 diabetes * blood glucose criteria must be met * body mass index (bmi) in the range 22-45 exclusion criteria: * history of type 1 diabetes * evidence of significant diabetic complications * serious cardiovascular events within the past 6 months * laboratory value abnormalities as defined by the protocol * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
maternal oral therapy to reduce obstetric risk kids

Conditions: Periodontitis; Autism; Premature Infants

Summary: the principal objective was to conduct a 5 year; multi-center, observational follow-up study enrolling infants born to mothers who participated in the motor clinical trial to determine the effects of maternal periodontal therapy during pregnancy on neonatal morbidity and mortality and whether this will result in lower incidence of functional neurological impairment.

a total of 525 infants where planned to be enrolled at the 3 performance sites. the number of infants enrolled at each site depended on past motor recruitment rates, and the observed delivery rate of high risk babies at that site. infants were enrolled from both the high risk and low risk groups. the intended sample size was fixed, over sampling among the low risk group and was used to assure the sample size. the data coordinating center (dcc) identified and provided each clinical site with participant listings of all motor high risk births and a randomly ordered sample of low risk births for enrollment into the study. mothers where approached by motor or motorkids personnel to ascertain participant interest in enrolling their infant. once consent was obtained, infants were followed and tracked until scheduled for the follow-up exams at age 24 months +/- 2 months adjusted age.

Eligibility criteria:
inclusion criteria: * all infants born to mothers enrolled to motor study prior to 35 weeks gestational age, * all small for gestational age (sga) infants and all infants born after 37 weeks gestation and who were appropriate for gestational age are eligible for enrollment. * all infants born \< 34 weeks gestation and all sga infants will be considered a high risk infant and will be recruited for enrollment. * appropriate weight for gestational age infants born after 37 weeks will be considered low risk infants and a random sample of these infants will be recruited for enrollment. exclusion criteria: * only a random sample of the low risk group will be recruited.
a study comparing tretinoin gel microsphere, 0.1% and retin-a micro ® gel microsphere, 0.1% in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: to demonstrate the therapeutic equivalence and safety of tretinoin gel microsphere, 0.1% (taro pharmaceuticals u.s.a, inc.) and retin-a micro® (tretinoin) gel microsphere, 0.1% (valeant) in the treatment of acne vulgaris.

a multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing tretinoin gel microsphere, 0.1% (taro pharmaceuticals u.s.a, inc.) and retin-a micro® (tretinoin) gel microsphere, 0.1% (valeant) in the treatment of acne vulgaris.

Eligibility criteria:
inclusion criteria: * healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. * subjects who are 18 years of age or older (up to the age of 40) must have provided irb approved written informed consent. subjects ages 12 to 17 years of age, inclusive, must have provided irb approved written assent * subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the investigator's global assessment (iga) exclusion criteria: * female subjects who are pregnant, nursing or planning to become pregnant during study participation * subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients. * subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
efficacy and safety of las 34273 in patients with moderate to severe stable chronic obstructive pulmonary disease(copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: to evaluate the efficacy and safety of las 34273 compared to placebo in patients with moderate to severe copd during one year of treatment.


Eligibility criteria:
inclusion criteria: * males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable copd exclusion criteria: * history or current diagnosis of asthma, recent respiratory tract infection or acute copd exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Keywords: copd lung function exacerbations quality of life
association of air quality and myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: besides classical cardiovascular risk factors such as smoking, obesity, elevated cholesterol levels and diabetes there are also acute factors potentially triggering acute coronary events. the impact of various substances and air pollution are described. particulate matter, especially with small particle size (\<2.5µm) has been shown to have a positive correlation with myocardial infarctions. however, other studies failed to show this correlation. with respect to nitric oxydes the majority of published studies detected a significant correlation with myocardial infarction, too, although a highly ranked publication failed to show the same result. in addition data on the impact of sulfur dioxide and carbon monoxide concentration on cardiac events is very heterogeneous. published data indicates additive effects of age and other epidemiological variables suggesting the need of a multivariate analysis. the rationale of the study is to test if the above mentioned air pollution factors have a significant and independent impact on the incidence of myocardial infarctions

the analysis will be performed in a well characterized patient cohort of 12.000 myocardial infarctions within 10 years being invasively diagnosed at the catheterisation centers of the styrian capital graz.

Eligibility criteria:
inclusion criteria: * myocardial infarction being confirmed or treated in the cathlab exclusion criteria: * none
anxiolytic effect of lavender oil on orthognathic surgery patients

Conditions: Anxiety; Osteotomy

Summary: the aim of this study is to determine the possible reducing effects of different concentrations of lavender oil on preoperative anxiety in orthognathic surgery patients who have high anxiety during preoperative wait.

preoperative anxiety is a common problem. it has long been known that surgical operations, unconsciousness, the risks of the operation itself, and the pain to be encountered in the future can cause a considerable amount of anxiety. anxiety is associated with an uncertain psychological distress, and may vary to minor disturbances to extreme stress. depending on the severity of the anxiety, preoperative anxiety can affect how well the patient understands the information about the surgery. in addition, stress factors such as interleukins released in the body in anxiety may negatively affect both surgical and post-surgical periods. we want to help patients improve their satisfaction by reducing their anxiety levels and ensure they have a better surgical experience. in addition, anxiety can also prevent active participation in the treatment of the patient during postoperative recovery. sedatives and other anxiolytic agents may be prescribed to prevent this condition. however, these methods can have side effects. the physical and psychological effects of essential oils and traditional medicine practices as aromatherapy has been used for a long time and has potency to reduce using sedatives. lavender oil is a fragrance that many of us have experienced in growing up at home and is also popular today. the lavender plant belongs to the labitae family and has been used for centuries in dried or essential oil form. lavender obtained from flower heads and leaves with vapor distillation. traditionally, this oil is believed to be beneficial for antibacterial, antifungal, muscle relaxant, sedative, antidepressant effects and for burn and insect bites. nowadays it is used for aromatherapy and antibacterial and pleasant fragrance material which is used in soaps and cosmetic products. this oil has also been specifically investigated and is an essential oil scientifically shown to reduce patient anxiety before various surgeries. however, the anxiolytic effect of this essential oil has not been investigated for orthognatic surgery patients and there is very few studies investigating different concentrations. the aim of our study is to investigate whether the different concentration of lavender oil diffused in the preoperative environment of orthognathic surgery patients reduces preoperative anxiety.

Eligibility criteria:
inclusion criteria: * to undergo orthognathic surgery * to be over 18 years old. * volunteering to fill pre-operative anxiety tests exclusion criteria: * hypersensitivity to lavender and its products. * being on any medication. * being a psychiatric or psychological problem and being under treatment. * current upper airway infection or asthma story. * not want to be involved in the work.

Keywords: preoperative anxiety orthognathic surgery lavender oil
early childhood, home injuries, mothers ' knowledge, mothers' attitude

Conditions: Home Injury

Summary: home-related injuries among early childhood: rural mothers' knowledge, attitudes and practice regarding first aid in matrouh governorate, egypt keywords: home injuries, early childhood, rural mothers, first aid, matrouh governorate.

implement health education class to rural mothers about first aid measures to be taken for their injured children"

Eligibility criteria:
inclusion criteria: * the mothers have normal preschool children less than 6 years regardless the child gender. * educated (minimum accepted level of education is completion of primary education) * interested \& willing to participate in the study. exclusion criteria: -

Keywords: home injuries early childhood rural mothers first aid
laparoscopy-assisted total gastrectomy for clinical stage i gastric cancer (klass-03)

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the safety and feasibility of laparoscopy-assisted total gastrectomy for early upper gastric cancer compared with open total gastrectomy. this study will performed via prospective, multicenter design.

gastric cancer remains one of the most common neoplasms in asia and some western countries, although the incidence is decreasing worldwide. recently,as the rate of detection of early gastric cancer has increased and surgical techniques have been developed, laparoscopic procedures have been introduced and tried for the treatment of early-stage gastric cancer. already the prospective, randomized trials for safety and oncologic outcomes of laparoscopy-assisted distal gastrectomy for gastric cancer had been tried, but the large-scaled, prospective study for laparoscopy-assisted total gastrectomy (latg) is seldom. one reason for the low popularity is that latg requires the dissection of lymph nodes at the splenic hilum or along the short gastric arteries and the other reason is that the reconstruction after total gastrectomy is also more complicated. the third reason is that the chance for total gastrectomy is less frequent than distal gastrectomy because of the low incidence of upper gastric cancer. this klass-03 trial is a prospective, multicenter trial for latg for early upper gastric cancer. the primary purpose of this study is to evaluate the incidence of postoperative morbidity and mortality and the second purpose is to evaluate the surgical outcomes after several methods of reconstruction in laparoscopic total gastrectomy and the postoperative course of latg patients.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy * range of age ; over 20 years to under 80 years * preoperative stage : ct1n0m0, ct1n1m0, ct2n0m0 (7th uicc) * the patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction * the gastric cancer which is not included the indication of the endoscopic mucosal dissection * ecog (eastern cooperative oncology group) performance status; 0 and 1 * asa (american society of anesthesiology) score ; 1, 2, 3 * written informed consent exclusion criteria: * the patient who shows distant metastasis under preoperative examination * the patient with medical history for upper abdominal surgery with open method in the past * the patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past(remnant stomach cancer) * the patient with double cancer synchronous or metachronous within 5 years * enlarged lymph nodes of the splenic hilum in the preoperative evaluation * the patient who has been enrolled other clinical study within 6 months * vulnerable patients who lacks mental capacity and are pregnant or planning a pregnancy

Keywords: gastric cancer, laparoscopy-assisted total gastrectomy
multi-center study on performance of the ponto implant system using minimally invasive ponto surgery (in adult patients)

Conditions: Hearing Loss

Summary: this prospective, multi-center study funded by oticon medical ab will be conducted at six clinical sites in north america. patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (bahs) will be included in the study. the total number of participants included in the study will be 64. the purpose of this study is to investigate the rate of successful bahs use after implantation of the ponto implant system using the surgical technique minimally invasive ponto surgery (mips).

this prospective, multi-centre study funded by oticon medical ab will be conducted at six clinical sites in north america. patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (bahs) will be included in the study. the total number of participants included in the study will be 64. patients who are withdrawn from the study prior to completion will not be replaced. the purpose of this study is to investigate the rate of successful bahs use after implantation of the ponto implant system using the surgical technique minimally invasive ponto surgery (mips). the implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. the primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines. * normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected. * skin thickness of 12mm or less at the implant site exclusion criteria: * patients undergoing re-implantation * patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales. * diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus * known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator. * any other known condition that the investigator determines could interfere with compliance or study assessments.